GDA-501, NAM enabled NK Cell Therapy, Demonstrates Promising Antitumor Activity Against HER2+ Cancers
November 07 2022 - 08:00AM
Business Wire
Preclinical data presented at Society of
Immunotherapy of Cancer’s 37th Annual Meeting shows proprietary NAM
technology expands NK cells, enhances functionality, increases
antitumor activity, and improves homing to targeted cancer
cells
Data demonstrates that genetically modified NK
cell GDA-501 enhances potency, persistence and cytotoxicity against
cancer cells expressing HER2
More than 100,000 patients in US have cancers
that express HER2
Gamida Cell Ltd. (Nasdaq: GMDA), the global leader in the
development of NAM-enabled cell therapies for patients with solid
and hematological cancers and other serious diseases, today
announced encouraging preclinical data on GDA-501, a genetically
modified NAM (nicotinamide) Natural Killer (NK) pre-clinical cell
therapy candidate from Gamida Cell’s expanding pipeline of cell
therapy candidates. The data will be presented at the Society for
Immunotherapy of Cancer’s 37th Annual Meeting taking place in
Boston, MA from November 10-12, 2022.
NK cells have generated significant interest as potential new
treatment options for patients with cancers. In pre-clinical and
clinical studies, Gamida Cell’s proprietary NAM technology has
demonstrated successful expansion of NK cells, enhanced
functionality, increased cytotoxic activity as well as creating a
protective effect against oxidative stress and improved homing to
targeted blood and solid tumor cancers.
“Our proprietary NAM technology enhances desirable cancer
fighting qualities across a broad range of innate and adaptive cell
types, including NK cells. As shown in our SITC poster, by
optimizing downstream signaling we were able to directly enhance NK
cell activity resulting in potent cytotoxicity against
HER2-expressing cells. These results suggest that GDA-501
represents a unique allogeneic cell therapy candidate potentially
targeting HER2+ solid tumors,” said Yona Geffen, Ph.D., Vice
President, Research and Development at Gamida Cell. “These data
further validate our NAM technology and our pipeline of genetically
modified NK cell therapy candidates that offer the potential to
improve clinical outcomes for patients with cancers, including
cancers that express HER2.”
The success of immune cell therapies has been limited in solid
tumors due to multiple barriers, including immunosuppressive tumor
microenvironment, inefficient trafficking, and heterogeneity of
tumor antigens. In a poster presentation titled, “Engineered NAM-NK
cells with HER2-CAR expression demonstrate increased cytotoxicity
against HER2-expressing solid tumors”, GDA-501, a genetically
modified HER2-CAR NAM-NK cell, displayed significantly enhanced and
persistent in vitro cytotoxicity and potency when cultured with
HER2+ targeted cancer cells. Cryopreserved GDA-501 significantly
inhibited tumor growth of a HER2+ solid tumor model in vivo. These
preclinical data demonstrate potent antitumor activity and suggest
that GDA-501 represents a unique potential treatment option using
an allogeneic NAM-enabled cell therapy candidate for this poor
prognostic group of patients with cancers that express HER2.
The GDA-501 poster (abstract #273) will be presented in Hall C
on Thursday, November 10, 2022, from 9:00 AM EST to 9:00 PM EST.
The poster presentation is publicly available at
www.sitcancer.org.
About NAM Technology Our NAM-enabling technology is
designed to enhance the number and functionality of targeted cells,
enabling us to pursue a curative approach that moves beyond what is
possible with existing therapies. Leveraging the unique properties
of NAM (nicotinamide), we can expand and metabolically modulate
multiple cell types — including stem cells and natural killer cells
— with appropriate growth factors to maintain the cells’ active
phenotype and enhance potency. Additionally, our NAM technology
improves the metabolic fitness of cells, allowing for continued
activity throughout the expansion process.
About GDA-501 Gamida Cell expanded the use of its
NAM-enabled technology to create GDA-501, an allogeneic innate NK
cell therapy candidate for the potential treatment of HER2+ solid
tumors. Human epidermal growth factor receptor 2 (HER2) is a
tyrosine kinase receptor growth-promoting protein expressed on the
surface of many types of tumors including breast, gastric, lung and
colorectal cancers.1 GDA-501 is genetically modified with a
chimeric antigen receptor (CAR) to target HER2 by optimizing
downstream signaling which directly enhances GDA-501 cytotoxicity.
In vitro data demonstrated potent cytotoxicity against
HER2-expressing cells. As a result, HER2-CAR may be used to target
multiple HER2+ solid tumors. For more information about GDA-501,
please visit https://www.gamida-cell.com.
About Gamida Cell Gamida Cell is pioneering a diverse
immunotherapy pipeline of potentially curative cell therapy
candidates for patients with solid tumor and blood cancers and
other serious blood diseases. We apply a proprietary expansion
platform leveraging the properties of NAM to allogeneic cell
sources including umbilical cord blood-derived cells and NK cells
to create therapy candidates with potential to redefine standards
of care. These include omidubicel, an investigational product under
review with the FDA as a potential life-saving alternative for
patients in need of bone marrow transplant, and a line of modified
and unmodified NAM-enabled NK cells targeted at solid tumor and
hematological malignancies. For additional information, please
visit www.gamida-cell.com or follow Gamida Cell on LinkedIn,
Twitter, Facebook or Instagram at @GamidaCellTx.
Cautionary Note Regarding Forward Looking Statements This
press release contains forward-looking statements as that term is
defined in the Private Securities Litigation Reform Act of 1995,
including with respect to timing of initiation and progress of, and
data reported from, the non-clinical and clinical trials of Gamida
Cell’s product candidates (including GDA-501), and the potentially
life-saving or curative therapeutic and commercial potential of
Gamida Cell’s product candidates (including GDA-501). Any statement
describing Gamida Cell’s goals, expectations, financial or other
projections, intentions or beliefs is a forward-looking statement
and should be considered an at-risk statement. Such statements are
subject to a number of risks, uncertainties and assumptions,
including those related to the impact that the COVID-19 pandemic
could have on our business, and including the scope, progress and
expansion of Gamida Cell’s clinical trials and ramifications for
the cost thereof; clinical, scientific, regulatory and technical
developments; and those inherent in the process of developing and
commercializing product candidates that are safe and effective for
use as human therapeutics, and in the endeavor of building a
business around such product candidates. In light of these risks
and uncertainties, and other risks and uncertainties that are
described in the Risk Factors section and other sections of Gamida
Cell’s Quarterly Report on Form 10-Q, filed with the Securities and
Exchange Commission (SEC) on August 15, 2022, as amended, and other
filings that Gamida Cell makes with the SEC from time to time
(which are available at http://www.sec.gov), the events and
circumstances discussed in such forward-looking statements may not
occur, and Gamida Cell’s actual results could differ materially and
adversely from those anticipated or implied thereby. Although
Gamida Cell’s forward-looking statements reflect the good faith
judgment of its management, these statements are based only on
facts and factors currently known by Gamida Cell. As a result, you
are cautioned not to rely on these forward-looking statements.
1.Iqbal N, et al. Human Epidermal Growth Factor Receptor 2
(HER2) in Cancers: Overexpression and Therapeutic Implications. Mol
Biol Int. 2014;852748.
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version on businesswire.com: https://www.businesswire.com/news/home/20221107005437/en/
For investors: Courtney Turiano Stern Investor Relations,
Inc. Courtney.Turiano@sternir.com 1-212-362-1200
For media: Heather DiVecchia Director, Investor Relations
and Corporate Communications Heather@gamida-cell.com
1-617-892-9083
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